The following data is part of a premarket notification filed by Carilex Medical, Inc. with the FDA for Vt - 100, Vt - 200.
| Device ID | K173407 |
| 510k Number | K173407 |
| Device Name: | VT - 100, VT - 200 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | Carilex Medical, Inc. No. 77 Keji 1st Rd., Guishan Dist. Taoyuan City, TW 333 |
| Contact | Henry Kao |
| Correspondent | Henry Kao Carilex Medical, Inc. No. 77 Keji 1st Rd., Guishan Dist. Taoyuan City, TW 333 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-01 |
| Decision Date | 2018-08-09 |
| Summary: | summary |